Generic Name: sodium oxybate (SO dee um OX i bate)
Brand Name: Xyrem
Drug class: Miscellaneous anxiolytics, sedatives and hypnotics
Xyrem (sodium oxybate) is a central nervous system depressant. It is used to treat cataplexy (sudden loss of muscle strength) and reduce daytime sleepiness caused by narcolepsy in adults and children at least 7 years old.
Xyrem is also known as GHB, a known street drug of abuse. Because of the potential for abuse and the serious side effects that may occur, Xyrem is available only from a certified pharmacy under a special program called Xyrem REMS Program. Your doctor must be registered in the program in order to prescribe this medicine for you.
Warnings
Xyrem can slow or stop your breathing, even at regular doses or if you are also taking stimulant medicines.
Misuse of Xyrem can cause breathing problems, seizure, loss of consciousness, or death. Xyrem is available only from a certified pharmacy. Do not allow anyone else to use your medication.
Fatal side effects can occur if you use this medicine with alcohol, or with other drugs that cause drowsiness or slow your breathing.
Avoid taking other medicines that make you sleepy or slow your breathing. This includes cold or allergy medicine, opioid pain medicine, sedatives, muscle relaxants, seizure medicine, or medicine for depression, anxiety, or mental illness. Your doctor may need to change your treatment plan if you need to use any of these other medicines.
Because of the potential for abuse and the serious side effects that may occur, Xyrem is available only from a certified pharmacy. Do not allow anyone else to use your medication.
Before taking this medicine
Do not drink alcohol or take other sleep medicines together with Xyrem. Dangerous side effects or death could occur.
Do not give Xyrem to anyone who has a rare metabolic disorder called succinic semialdehyde dehydrogenase deficiency (which can cause mental or physical impairment).
To make sure Xyrem is safe for you, tell your doctor if you have ever had:
- a breathing disorder such as asthma, emphysema, or bronchitis;
- snoring, or sleep apnea (breathing stops during sleep);
- depression or suicidal thoughts;
- mental illness or unusual behaviors (anxiety, agitation, paranoia, aggression, hallucinations);
- a drug or alcohol addiction;
- kidney or liver disease;
- heart failure;
- if you are on a low-salt diet; or
- if you also take divalproex sodium (Depakote).
You may need to be on a low-salt diet while you are using Xyrem, especially if you have high blood pressure, kidney disease, or heart disease.
Tell your doctor if you are pregnant or breastfeeding.
How should I take Xyrem?
Take Xyrem exactly as it was prescribed for you. Follow all directions on your prescription label and read all medication guides or instruction sheets. Xyrem can slow or stop your breathing, even at regular doses or if you are also taking stimulant medicine.
Xyrem may be habit-forming. Misuse can cause addiction, overdose, or death. Keep the medication in a place where others cannot get to it. Selling or giving away this medicine is against the law.
Do not allow anyone else to use this medicine.
Take Xyrem at least 2 hours after a meal. It is important to take your dose at the same time each night.
Xyrem must be taken at bedtime and again 2.5 to 4 hours later. This medicine works very fast and should be taken while you are sitting in bed ready for sleep. Prepare both doses while you are getting ready for bed. Place the second dose next to your bed so you can take it without getting up. You will most likely need to set an alarm to awaken for the second dose.
Each dose of Xyrem must be mixed with two ounces (one quarter cup) of water in the child-resistant dosing cups provided with the medication. Both doses must be used within the same night. Throw away any dose that has been mixed with water but not used within 24 hours of mixing.
Do not stop using Xyrem suddenly, or you could have unpleasant withdrawal symptoms. Ask your doctor how to safely stop using this medicine.
Your doctor will need to check your progress every 3 months.
Store at room temperature away from moisture and heat.
Keep track of your medicine. You should be aware if anyone is using it improperly or without a prescription.
Do not keep leftover Xyrem liquid. Ask your pharmacist where to locate a drug take-back disposal program. If there is no take-back program, pour any unused liquid medicine down a sink drain.
Dosing information
Usual Adult Dose for Narcolepsy:
Initial dose: 4.5 g orally per day, divided and given as 2 equal doses with the first dose taken at bedtime and the second dose taken between 2.5 to 4 hours later
-The dose may be increased by 1.5 g (OR 0.75 g/dose) orally per night in weekly intervals
Maintenance dose: 6 to 9 g/day
Maximum dose: 9 g/day
Comments:
-Both doses should be diluted at the same time at night.
-Some patients may need to set an alarm to take the second dose.
-Patients should remain in bed after taking each dose.
-If the second dose is missed, patients should skip the dose and should not take this drug until the next night.
-Dosing may be gradually titrated, and doses should be determined by efficacy and tolerability.
Use: Treatment of cataplexy in narcolepsy and excessive daytime sleepiness (EDS) in patients with narcolepsy
Usual Adult Dose for Idiopathic Hypersomnia:
2 times a night regimen:
-Initial dose: 4.5 g orally per day, divided and given as 2 equal doses
---The dose may be increased by 1.5 g (OR 0.75 g/dose) orally per night in weekly intervals
-Maintenance dose: 6 to 9 g/day
-Maximum dose: 9 g/day
Once a night regimen:
-Initial dose: 3 g orally per day, divided and given as 2 equal doses
---The dose may be increased by 1.5 g (OR 0.75 g/dose) orally per night in weekly intervals
-Maintenance dose: 3 to 6 g/day
-Maximum dose: 6 g/day
Comments:
-This drug may be given in divided doses or as a single dose.
-Dosing may be gradually titrated, and doses should be determined by efficacy and tolerability.
-Patients may respond better with the first dose given at bedtime and the second dose given between 2.5 to 4 hours later.
Use: Treatment of idiopathic hypersomnia
Usual Pediatric Dose for Narcolepsy:
7 years and older:
Less than 20 kg: Specific dosing recommendations are not available.
20 to less than 30 kg:
-Initial dose: Up to 2 g orally per day, divided and given as 2 equal doses with the first dose taken at bedtime and the second dose taken between 2.5 to 4 hours later
-Maintenance dose: The dose may be increased by 1 g (OR 0.5 g/dose) orally per night at 1 to 2-week intervals up to 6 g/day.
-Maximum dose: 6 g/day
30 to less than 45 kg:
-Initial dose: Up to 3 g orally per day, divided and given as 2 equal doses with the first dose taken at bedtime and the second dose taken between 2.5 to 4 hours later
-Maintenance dose: The dose may be increased by 1 g (OR 0.5 g/dose) orally per night at 1 to 2-week intervals up to 7.5 g/day.
-Maximum dose: 7.5 g/day
45 kg and greater:
-Initial dose: Up to 4.5 g orally per day, divided and given as 2 equal doses with the first dose taken at bedtime and the second dose taken between 2.5 to 4 hours later
-Maintenance dose: The dose may be increased by 1.5 g (OR 0.75 g/dose) orally per night at 1 to 2-week intervals up to 9 g/day.
-Maximum dose: 9 g/day
Comments:
-Patients who sleep more than 8 hours/night may be given the first dose at bedtime or after an initial period of sleep.
-Patients 7 years and older and weighing less than 20 kg may be given lower initial, maximum, maintenance, and total maximum nightly doses.
-Unequal doses may be required in some patients to attain an optimal response to treatment.
-Both doses should be diluted at the same time at night.
-Some patients may need to set an alarm to take the second dose.
-Patients should remain in bed after taking each dose.
-If the second dose is missed, patients should skip the dose and should not take this drug until the next night.
-Dosing may be gradually titrated, and doses should be determined by efficacy and tolerability.
Use: Treatment of cataplexy in narcolepsy and EDS in patients with narcolepsy
What happens if I miss a dose?
Take the medicine as soon as you can, but only during your normal sleeping hours (wait at least 2 hours after eating). Do not take two doses at one time.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of sodium oxybate can be fatal.
Overdose symptoms may include sweating, vomiting, severe confusion, loss of balance or coordination, or seizure (convulsions).
What to avoid
Do not drink alcohol. Dangerous side effects or death could occur.
Sodium oxybate will cause drowsiness and can impair your thinking or reactions. You may still feel sleepy the morning after taking this medicine. Wait at least 6 hours or until you are fully awake before you drive, operate machinery, pilot an airplane, or do anything that requires you to be awake and alert.
Do not take other sleep medicines together with Xyrem.
Xyrem side effects
Get emergency medical help if you have signs of an allergic reaction to Xyrem: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
- weak or shallow breathing, breathing that stops for short periods of time;
- sleepwalking, waking and confused behavior at night;
- confusion, paranoia, hallucinations (seeing or hearing things);
- depression, anxiety, unusual or unpleasant thoughts; or
- suicidal thoughts or actions.
Common Xyrem side effects may include:
- sleepwalking;
- headache;
- weight loss;
- loss of appetite;
- drowsiness, dizziness;
- bed-wetting;
- nausea, vomiting; or
- tremors.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What other drugs will affect Xyrem?
Using Xyrem with other drugs that make you drowsy or slow your breathing can cause dangerous side effects or death. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures.
Your doctor may need to change your treatment plan if you need to use any of these other medicines.
Other drugs may interact with sodium oxybate, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.